During the fourth International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) COVID-19 media briefing, one thematic dominated: collaboration. With Eli Lilly chairman and CEO David Ricks, also president of IFPMA; Roche CEO Dr Severin Schwan, also vice-president of IFPMA; Pfizer chairman and CEO Dr Albert Bourla; MSD (Merck & Co. in the US and Canada) chairman and CEO Kenneth Frazier; and Gilead chairman and CEO Daniel O’Day in attendance, the high-level dialogue covered clinical trial progresses, socioeconomic inequalities in health outcomes, and supply chain complexities. What is striking is that all present were in agreement that the industry has witnessed a remarkable level of collaboration in its COVID-19 response and efforts over the past ten months.
The speed at which we’re moving is truly unprecedented in the history of our industry or frankly, in the face of any other disease
David Ricks, Eli Lilly
As Lilly’s Ricks marvelled, “this industry is collaborating in ways I haven’t seen in my 25 years of working.” For him, this is one of the biggest aspects behind the pace at which the industry has managed to work, pointing out, “the speed at which we’re moving is truly unprecedented in the history of our industry or frankly, in the face of any other disease – a disease that was just genetically identified as a target nine months ago. We already have approved treatments and we have a pipeline of over three hundred possible treatments and of course, many vaccines candidates.”
The first COVID-19 treatment to be approved in the world was Gilead’s remdesivir, and to date, it has received approval or conditional approval in over 50 countries. Nevertheless, the company is continuing to investigate its potential as part of combination therapy. CEO O’Day outlined, “remdesivir had such an impact on hospitalized patients as a standalone agent [that] we have collaborated with companies that are represented here today to see if a combination approach [can] get an even stronger and more durable effect for patients,” adding that “this is characteristic with viral diseases, [like] HIV and Hepatitis C.”
Roche’s Actemra®, whose standalone Phase III COVID-19 clinical trial, unfortunately, failed to generate a positive readout, is one of the drugs being explored in another Phase III trial together with remdesivir.
We knew what kind of a situation we were in. We can’t do anything alone on this scale and magnitude
Daniel O’Day, Gilead
Another area where collaboration has been – and will continue to be – essential is manufacturing and supply chain. As the first product to have to contend with the mammoth task of addressing an ongoing global pandemic, remdesivir is a model to follow. O’Day explained, “we knew what kind of a situation we were in. We can’t do anything alone on this scale and magnitude.” For that reason, Gilead reached out and is now working with over 30 partners globally across their entire supply chain. Gilead has also signed non-exclusive voluntary licensing agreements with generic players in Egypt, India and Pakistan to manufacture remdesivir for distribution in 127 countries.
Pfizer is one of Gilead’s global manufacturing partners for remdesivir, and chairman and CEO Bourla recalled, “the discussions started very early. I called [O’Day] and I told him, Dan, I know you are working on China and we have a lot of capabilities in China. If you need it, it’s yours. We then put our manufacturing people together to see if they can do something and eventually, we came to this collaboration.” Ultimately, he emphasized, “one thing is for science to develop a solution. The other thing is for technology to be able to scale up in a manner appropriate for the pandemic so that people have access to vaccines and therapeutics.”
I told [Gilead’s Daniel O’Day], I know you are working on China and we have a lot of capabilities in China. If you need it, it’s yours
Albert Bourla, Pfizer
This strategy of external partnership development is in conjunction with their own internal efforts to optimize the manufacturing and supply chain processes. O’Day revealed, “remdesivir [has] a very complex small molecule manufacturing process. Thanks to the creativity of our scientists, we were able to take the 12-month [production] cycle time [in January 2020] down to six months.” In addition to that, Gilead also made the atypical decision to start investing in manufacturing capacity and ramp up supply even before the drug had been approved in any market because, as O’Day put it, “we knew that in these extraordinary times, if this medicine was going to work, we had to be prepared. Thanks to the investment, the efforts and the partnerships, we will be in a position to meet global demand starting next month, which is pretty extraordinary.”
Like Gilead, Pfizer is also building up its manufacturing capabilities ahead of time. The company is currently enrolling patients for their Phase III COVID-19 vaccine trial. Bourla indicated matter-of-factly, “we have already manufactured hundreds of thousands of doses. If it is successful, we continue manufacturing and we will have enough to provide the world. If not, we write it off and move on. All we will lose is money.”
Roche’s Schwan is in agreement about the critical role that manufacturing has to play in this situation. In August, the company teamed up with US biopharma company Regeneron for the latter’s two-antibody cocktail. This collaboration, under which Regeneron will distribute the treatment in the US and Roche will be responsible for distribution everywhere else, is expected to at least more than triple the potential global supply of this therapy. For Schwan, the rationale was pretty obvious: looking at neutralizing antibodies as treatments, “the number one limitation we [as an industry] have is global manufacturing capacities and [i]t’s very difficult to scale up manufacturing capacities for antibodies. Roche is actually the company with one of the biggest [manufacturing] capacities for antibodies.
He rhetorized, “just imagine what a tragedy it would be if every company would sit on its own manufacturing capacities, and then one company finds a breakthrough therapy but is not able to produce it.” It is for this reason, he expressed, that “in this very special situation, we [are looking at] how we can bring all our resources and capabilities together. I have never seen this in my entire career. Typically, we are fierce competitors and we would not give away our manufacturing capacities.”
COVID-19 has been able to shine a light on the health disparities both within countries and between them
Kenneth Frazier, MSD
Rather poignantly, MSD chairman and CEO Frazier illustrated the big picture behind these industry efforts: serious, urgent and unequal global needs. “It’s important to recognize that COVID-19 has been able to shine a light on the health disparities both within countries and between them, including the range of diseases associated with COVID-19 risk and access to health care. In the US, statistics show that COVID-19 is disproportionately impacting communities and underrepresented groups across the nation, with African Americans experiencing higher rates of serious infections of any group. Globally pre-existing inequalities are also exacerbating the disease in certain areas.”
For him, this means “we must make medicines and vaccines accessible and affordable globally. There will not be a silver bullet. We’re going to need great cooperation and investment across this industry.”
On this note, Lilly’s Ricks reminded the audience, “collectively, our industry spends more on R&D than all governments globally combined. The private sector is a powerful force to conquer disease. We hold ourselves to very high scientific standards. Because of all those things, I believe we will make significant progress against the virus. We’ve already made a lot. [This crisis] will end because of science, with industry being a big part of the solution.”